US FDA issues a CRL for GlaxoSmithKline's sNDA on Avodart for prostate cancer risk reduction

UK pharma giant GlaxoSmithKline (LSE: GSK) says that it has received a Complete Response letter from the US Food and Drug Administration for the supplemental New Drug Application (for Avodart (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

GSK did not explain the contents of the CRL, other than saying such notifications are sent if the agency cannot approve an application in its present form, but last month an FDA advisory panel voted 14-2 not to recommend approving the additional indication for the benign prostatic hyperplasia treatment, deciding the risks outweighed its benefits (The Pharma Letter December 2, 2010). At that time, the head of the FDA's office of oncology drug products said the drug should be held to a higher standard because it would be used in healthy men, unlike traditional cancer treatments.

This notification refers solely to the supplemental file specific to a prostate cancer risk reduction indication and not the existing FDA-approved uses. Avodart is approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery. In combination with the alpha-blocker tamsulosin, Avodart is also approved for the treatment of symptomatic BPH in men with an enlarged prostate.